Risk analysis is a structured tool for the evaluation of potential problems which could be encountered in many situations (riding in an airplane, taking a drug, or using a medical device.) Risk is everywhere, with varying likelihoods and consequences. Risk analysis is now routinely used during the design phase for medical devices to manage risk.
The Risk Management Plan should identify the risk management activities you anticipate and plan throughout the product’s lifecycle.
A Risk Management Plan must include the following criteria:
Scope of the Risk Management activities. Define the product included. It is possible to have multiple products described within a single Risk Management Plan.
Describe the intended use of the product(s).
Identify all Risk Management activities planned throughout the product lifecycle.
Define roles and responsibilities. Identify the Risk Management team that will be reviewing and approving risk documentation.
Criteria for the product’s risk acceptability. (Note, that often times this is likely to be defined within your Risk Management Procedure.)
Specify methods to verify Risk Control measures are implemented and reduce risks.
Define how post-production information will be captured and fed into Risk Management activities for the product.
Risk to safety of patients, users, handlers and Regulatory Product liability must all be managed. ISO 14971 is recognized by:
- Manufacturers must conduct and document a risk management process. ISO 13485 refers to ISO 14971 for guidance related to risk management.
- The U.S. Food and Drug Administration (FDA)
- The EU has made it mandatory.
The Risk Management Plan is dynamic and should be revisited and updated often. This is not a do it one time and it’s done activity.
The Risk Management Plan evolves and should be kept current–even after product development is completed.